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Generated: January 19, 2019

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Nevirapine - Generic Drug Details

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What are the generic sources for nevirapine and what is the scope of nevirapine patent protection?

Nevirapine is the generic ingredient in three branded drugs marketed by Aurobindo, Cipla, Boehringer Ingelheim, Alvogen Malta, Apotex Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Sandoz Inc, Tech Organized, Hetero Labs Ltd Iii, Micro Labs Ltd, Mylan Labs, Prinston Inc, and Strides Pharma, and is included in twenty-five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nevirapine has thirty-two patent family members in twenty-seven countries.

There are twenty drug master file entries for nevirapine. Seventeen suppliers are listed for this compound. There are seven tentative approvals for this compound.

Medical Subject Heading (MeSH) Categories for nevirapine
Synonyms for nevirapine
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[2,3-e:3',2'-b][1,4]diazepin-6-one
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[2,3-e:3',2'-b][1,4]diazepin-6-one & PRO 140 (Anti-CCR5 monoclonal antibody)
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
11-cyclopropyl-4-methyl-5H-dipyrido[[?],[?]][1,4]diazepin-6-one
11-cyclopropyl-4-methyl-5H-dipyrido[2,3-b:3',2'-e][1,4]diazepin-6-one
11-Cyclopropyl-4-methyl-5H-dipyrido[3,2-b
11-CYCLOPROPYL-4-METHYL-5H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPIN-6(11H)-ONE
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido-[3,2-b:2',3'-e][1,4]diazepin-6-one
11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one
11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO[2,3-B:3',2'-E][1,4]DIAZEPIN-6-ONE
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b :2',3'-e][1,4 ]diazepin-6-one
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2 ,3 -e][1,4]diazepin-6-one
11-Cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2', 3'-e][1,4]diazepin-6-one
11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPIN-6-ONE
11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO[3,2-B',3'-E][1,4]DIAZEPIN-6-ONE
129618-40-2
1vrt
2-cyclopropyl-7-methyl-2,4,9,15-tetraazatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3,5,7,12,14-hexaen-10-one
2-cyclopropyl-7-methyl-2,4,9,15-tetraazatricyclo[9.4.0.0;{3,8}]pentadeca-1(15),3,5,7,11,13-hexaen-10-one
2-CYCLOPROPYL-7-METHYL-2,4,9,15-TETRAAZATRICYCLO[9.4.0.0(3,8)]PENTADECA-1(11),3,5,7,12,14-HEXAEN-10-ONE
2-CYCLOPROPYL-7-METHYL-2,4,9,15-TETRAAZATRICYCLO[9.4.0.0(3),?]PENTADECA-1(11),3,5,7,12,14-HEXAEN-10-ONE
2-CYCLOPROPYL-7-METHYL-2,4,9,15-TETRAAZATRICYCLO[9.4.0.0(3),?]PENTADECA-1(11),3(8),4,6,12,14-HEXAEN-10-ONE
2-CYCLOPROPYL-7-METHYL-2,4,9,15-TETRAAZATRICYCLO[9.4.0.0(3),?]PENTADECA-1(15),3(8),4,6,11,13-HEXAEN-10-ONE
2-cyclopropyl-7-methyl-2,4,9,15-tetraazatricyclo[9.4.0.0(3),]pentadeca-1(15),3(8),4,6,11,13-hexaen-10-one
2hny
5-Cyclopropyl-9-methyl-5,10-dihydro-4,5,6,10-tetraaza-dibenzo[a,d]cyclohepten-11-one
5H-Dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one, 5,11-dihydro-11-cyclopropyl-4-methyl-
618N402
6H-Dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one, 11-cyclopropyl-5,11-dihydro-4-methyl-
6H-DIPYRIDO[2,3-B:3',2'-E][1,4]DIAZEPIN-6-ONE, 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-
6H-dipyrido[2,3-e:3',2'-b][1,4]diazepin-6-one, 11-cyclopropyl-5,11-dihydro-4-methyl-
6H-DIPYRIDO[3,2-B:2',3'-E][1,4]DIAZEPIN-6-ONE, 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-
99DK7FVK1H
AB0013383
AB00393001_16
AB00393001_17
AB00393001-13
AB00393001-15
AB07544
AB2000266
AC-643
AC1L1I81
AJ-08226
AK143126
AKOS005504351
ALBB-027264
AN-15635
BBL010768
BC206673
BDBM1434
BI RG 587
BI-RG 587
BI-RG-587
BI-RG-587 & CD4-IgG
BIDD:GT0326
Bio-0789
BIRG 0587
BIRG 587
BIRG-0587
BIRG-587
BIRG587
C07263
C15H14N4O
Cahill May Roberts Brand of Nevirapine
CAS-129618-40-2
CCG-100939
CHEBI:63613
CHEMBL57
CPD000048458
CS-2252
CTK8E7455
D00435
D0O2EM
DB00238
DR000811
DSSTox_CID_10787
DSSTox_GSID_31797
DSSTox_RID_78889
DTXSID7031797
F2173-0607
FT-0607215
H954
HMS2051J09
HMS2231O23
HMS3264D21
HMS3371E03
HMS3393J09
HMS3655I08
HSDB 7164
HY-10570
I02-0310
KB-64802
KS-00000KZF
KS-5019
LS-2289
MCULE-8608154492
MFCD00866928
MLS000084585
MLS000759409
MLS001055309
MLS001201730
MLS001424058
MLS006011423
MolPort-002-507-817
N0922
N11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e]-[1,4]diazepin-6-one & CD4-immunoadhesin
NC00189
NCGC00065890-02
NCGC00065890-03
NCGC00065890-04
NCGC00065890-05
NCGC00065890-07
NCGC00258324-01
NEV
NEVARAPINE
Nevirapine (anhydrous), European Pharmacopoeia (EP) Reference Standard
Nevirapine (JAN/USP/INN)
Nevirapine (Viramune)
Nevirapine [USAN:INN]
Nevirapine [USAN:USP:INN:BAN]
Nevirapine & CD4-IgG
Nevirapine & PRO 140
Nevirapine anhydrous
Nevirapine anhydrous, United States Pharmacopeia (USP) Reference Standard
Nevirapine for peak identification, European Pharmacopoeia (EP) Reference Standard
Nevirapine solution, 1.0 mg/mL in methanol, certified reference material
Nevirapine, pharmaceutical secondary standard; traceable to USP, PhEur
NON-NUCLEOSIDE RT INHIBITOR NEVIRAPINE
NQDJXKOVJZTUJA-UHFFFAOYSA-N
NSC 641530
NSC-641530
NSC-759902
NSC641530
NSC759902
NVP
Opera_ID_934
Pharmakon1600-01503842
PL004639
PL040500
PL044148
Promeco Brand of Nevirapine
R3924
RL01415
RT-014690
S1742
SAM001246551
SC-17266
SCHEMBL3318
SMR000048458
ST24038235
STK580320
Tox21 110982
Tox21_110982
Tox21_110982_1
Tox21_200770
UNII-99DK7FVK1H
Viramune
Viramune (TN)
Viramune IR
Viramune XR
Viramune, BI-RG 587, Nevirapine
Viramune;BI-RG 587
Viramune(TM)
Z1695906730
ZB000592
ZINC4778
Tentative approvals for NEVIRAPINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial50MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial200MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial200MGTABLET; ORAL

US Patents and Regulatory Information for nevirapine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs Ltd NEVIRAPINE nevirapine TABLET;ORAL 203080-001 May 22, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Strides Pharma NEVIRAPINE nevirapine TABLET;ORAL 078195-001 May 22, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 203411-001 Apr 3, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Alvogen Malta NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 204621-002 Nov 9, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cipla NEVIRAPINE nevirapine SUSPENSION;ORAL 207684-001 Aug 3, 2017 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 205258-001 Apr 3, 2014 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nevirapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim VIRAMUNE nevirapine SUSPENSION;ORAL 020933-001 Sep 11, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim VIRAMUNE XR nevirapine TABLET, EXTENDED RELEASE;ORAL 201152-001 Mar 25, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim VIRAMUNE nevirapine TABLET;ORAL 020636-001 Jun 21, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for nevirapine

Country Document Number Estimated Expiration
South Korea 101017862 ➤ Try a Free Trial
World Intellectual Property Organization (WIPO) 2008154234 ➤ Try a Free Trial
New Zealand 578664 ➤ Try a Free Trial
Ecuador SP099561 ➤ Try a Free Trial
Brazil PI0811732 ➤ Try a Free Trial
Australia 2008262031 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for nevirapine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021 Belgium ➤ Try a Free Trial PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
90022 Netherlands ➤ Try a Free Trial PRODUCT NAME: NEVIRAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION: CH 54393 19971223
/1999 Austria ➤ Try a Free Trial PRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
C/GB99/020 United Kingdom ➤ Try a Free Trial PRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205
C0019 France ➤ Try a Free Trial PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cipla
Argus Health
Fish and Richardson
Harvard Business School
Baxter
McKinsey
Merck
McKesson

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